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You know, thinking about what Cohera makes, resorbable surgical adhesives, could our DDAIP be useful to them? Or maybe their technology useful to us?
As if Pascoe doesn't have enough on his plate right now! I wish our execs would concentrate on their current job.
Anyway, here's more on the possible Viagra-Melanoma issue that just came out:
Published: Jun 3, 2014 | Updated: Jun 4, 2014
By Charles Bankhead, Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Action Points
Men who used the erectile-function drug sildenafil (Viagra) had almost twice the risk of melanoma compared with men who never used the drug, researchers found.
Note that sildenafil use did not influence the risk of squamous-cell or basal-cell skin cancer.
Men who used the erectile-function drug sildenafil (Viagra) had almost twice the risk of melanoma compared with men who never used the drug, a study of 26,000 men showed.
Recent sildenafil use was associated with an 84% greater risk of melanoma. Use of the drug had no association with the risk of nonmelanoma skin cancers, according to Jiali Han, PhD, of the Indiana University School of Public Health in Indianapolis, and co-authors. Moreover, erectile function per se did not correlate with melanoma risk, they reported in JAMA Internal Medicine.
"Our study cannot prove cause and effect," the authors concluded. "A longer follow-up and more detailed assessment of the dose and frequency of sildenafil use at multiple times in the [study cohort] would be necessary for future studies."
"Nevertheless, our data provide epidemiological evidence on possible skin adverse effects of PDE5A inhibitors [the sildenafil drug class] and support continued investigation of this relationship," they added.
Though just an association -- not proof of causality -- the link between sildenafil and melanoma does have a potential molecular basis, said Ryan Sullivan, MD, of Massachusetts General Hospital in Boston.
"Sildenafil may promote tumor growth, at least in tumor cells," Sullivan told MedPage Today. "There's plausibility, but this not causation as of yet. There's still a lot of work that needs to be done before we can definitively say that drugs for erectile dysfunction cause melanoma."
If the association proves to be a real relationship, then the effect on melanoma risk probably applies to all drugs in the PDE5-inhibitor class, he added.
The underlying biologic mechanisms of melanoma involve multiple molecular entities within a complex signaling pathway. Mutations in BRAF occur in about half of all melanomas. Drugs that target BRAF have demonstrated efficacy in the treatment of melanoma.
Recently, the enzyme phosphodiesterase 5A (PDE5A) was reported to be a downstream target of BRAF, the authors noted. Activated BRAF downregulates PDE5A to facilitate invasion and metastasis of melanoma cells. Additionally, other molecules in the melanoma-associated signaling pathway, notably NRAS, have been shown to downregulate PDE5A in melanoma cell lines.
"This indicates that PDE5A suppression by sildenafil use mimics an effect of BRAF/NRAS activation and thus may potentially function as one of the 'hits' for melanomagenesis," according to the authors' background information.
Two PDE5 inhibitors have been shown to promote melanin synthesis, which may stimulate melanoma development, they continued. The body of evidence led Han and colleagues to hypothesize the existence of an association between sildenafil use and melanoma.
To test the hypothesis, investigators analyzed data from the Health Professionals Follow-up Study (HPFS), which began in 1986 and has a total enrollment of 51,529 male health professionals ages 40 to 75. Each participant completed a health survey at baseline and then every 2 years.
In the 2000 follow-up survey, HPFS participants were asked whether they had undergone surgery or received other treatment for erectile dysfunction within the previous 3 months. With respect to sildenafil use, respondents were not asked to provide specific information about drug dosage or frequency of use.
The 2000 survey also included items related to erectile function before 1986, and from 1986 to 1986, 1990 to 1994, and 1995 to 2000, as well as during the past 3 months. Men who reported poor or very poor erectile function at or before 2000 were considered to have erectile dysfunction in 2000.
The HPFS questionnaires also included items related to risk factors for melanoma, such as hair color and skin type, number of lifetime sunburns, moles on the arms, state of residence at birth and at 15 and 30, and tendency to sunburn during adolescence.
Family history of melanoma was included in the 1990 and 1992 surveys. In 2008, the survey included items related to midday sun exposure at ages from high school to 60. Every biennial survey collected information about smoking, body mass index, and physical activity.
Men who completed the 2000 HPFS questionnaire provided the study population. Investigators excluded participants who had diagnoses of squamous-cell skin cancer, basal-cell skin cancer, or melanoma prior to 2000. Follow-up continued to the last completed questionnaire or the 2010 questionnaire, whichever came first.
The analysis included 25,848 men who had a mean baseline age of 64.8. The authors found that 5.3% of the men reported recent use of sildenafil, and 6.3% reported any use.
Sildenafil users tended to:
Be older and obese
Have a history of severe and blistering sunburns
Be more likely to undergo physical examinations
Be exposed to less sunlight as adults
From 2000 to 2010, 142 melanoma diagnoses were documented, as were 580 cases of squamous-cell skin cancer and 3,030 cases of basal-cell skin cancer.
In a multivariate analysis, men who reported current sildenafil use at baseline had a melanoma hazard ratio of 1.84 versus men who had never used the drug (95% CI 1.04-3.22). Men who reported any use of sildenafil had a similar melanoma risk (HR 1.94, 95% CI 1.14-3.22).
In contrast, sildenafil use did not influence the risk of squamous-cell or basal-cell skin cancer.
The increased risk of melanoma persisted among sildenafil users after exclusion of patients who had major comorbidities at baseline, including in increased risk with recent use (HR 2.24, 95% CI 1.05-4.78) and any use (HR 2.77, 95% I 1.32-5.85).
The study was supported in part by the National Institutes of Health.
Just spent the last hour reviewing SEC docs, mostly proxy filings. Since 2001, the BoD seems to have been a revolving door for itinerant PhDs, old lawyers, and very young businessmen. They seemed to rotate through the CEO position on a regular schedule. The one thing that was always taken care of was the self-awarded stock grants. To the tune that some of these directors/officers have millions of shares.
MILLIONS of shares for a company that couldn't shoot straight!
Yes, some of the directors managed to convince Fidelity and other funds to take substantial positions- but they have long since sold out.
Maybe if the company didn't bleed itself dry by giving every executive 100K, 200K, and 300K compensation packages when they weren't earning a dime, they wouldn't have found themselves in the position that forced them to sell away their main product.
Let's hope that this lineup can finally shoot straight. Let's see if they can actually earn what we pay them.
And that was the best deal Damaj could make? Boy was he taken to the cleaners!
Hey SB- I get the same feeling. Hopefully it will become a hit in the EU and Actavis just won't want to leave that revenue on the table- and therefore will bring the drug to market.
Of course, you're correct. What would be beneficial (or at least informative), would be for Pascoe to tell us that Actavis has no intention of selling back the rights because they do have a game plan. The lack of any useful info is what is so painful.
Of the eight 1,000+ share trades today, 6 were upticks for 17,500 shares and 2 were downticks for 5,200 shares. Institutions will buy on down days so as to not influence the price. I think we're seeing very quiet accumulation. Anything bought under $2.25 will easily be considered a brilliant move a few months from now, anything in the $2.10 range, simply genius.
I think this calm-before-the-storm has a few parents: the lackluster history (I'm being kind) of the company, the dearth of third-party investor information, the invisible analysis by the professional analysts who follow the company, and the shy executives who prefer to stay out of the road show circuit. I mean, really, if Pascoe and Martin aren't on the soapbox several more times a year, then they need to hire somebody who will get up there and say, "This is the safer way to better sex! We make it and several of the most respected pharmaceutical companies are partnering to sell it."
It doesn't help that Actavis is just sitting on it. That needs to be addressed big time.
I was on a team that researched the PC for a great household name insurance company that wanted to know if it could help the employees do their work more efficiently. At the time, employees who were lucky enough to have a terminal at their desk were either direct-connected or multiplexed into a mainframe. Out of the 8 members on the team, nobody thought of 'looking inside' the box and buying a fledgling startup named Microsoft that had written the operating system and some user software. Nobody thought of buying shares in Intel which made the processor. And these were the smartest folks in the company!
It turned out that at this first examination, we turned down the PC as not needed. Why have a PC on your desk when you already have the horsepower of an IBM System 360 (or Amdahl V6) mainframe on your terminal?
Thirty years later, the company has 40,000 laptops. And Microsoft and Intel are still in the box, humming right along.
What's this all mean you ask?
It means that change takes time. But over time, great changes do happen. Yes, the PDE5i pills have a grand head start and a huge following (ok, no pun intended!), but having a use-it-where-you-need-it-when-you-need-it cream is a game-changer. It will be a slow roll-out, but it will gather steam with every physician that hears positive results from happy patients. With every improvement to the DDAIP permeation enhancer, Vitaros will only get better.
Maybe 'low-double digit royalties' doesn't sound like much, but in a couple years as the rollouts complete and sales are increasing, it will amount to some solid income. Maybe APRI won't hit $5 for a year or two. Maybe it will take 3 or 5 years. Heck, the execs gave themselves options with expirations TEN YEARS out! Maybe they know how long these things take to happen and don't want to shortchange themselves.
Up to this point in the company's history, things have never looked so promising. Funds are starting to take or increase their positions. A pipeline is defined. New experienced faces are on the BoD.
Maybe little APRI isn't on everyone's radar. But once those prescription are filled and the customers read the fine print on the box and on the insert, Apricus will become known and many users will become shareholders.
So the stock's not running right now- no big deal. When royalties really start to hit the bottom line and funds are lining up to grab the few available shares, the price will move. I can easily imagine, when APRI starts to move, all the biotech fund managers asking their research analysts why APRI isn't in the portfolio?
That would be nice, but then, we're only the owners of the company! But hey, in a few short weeks, we won't even recall this discussion.
I think it's safe to presume that the executive team wants to see the price rise and rise substantially. After all, their options only become really valuable when the stock is over $5. Even if they are selling via the ATM, the dilution is negligible in the grand scheme of things.
Anyway, why would they sell shares now? In two weeks actual sales begin and everyone and his brother will be examining this stock as a possible home-run candidate. That interest will result in new buyers coming in and lifting the price. Why sell today at $2.30 when you can sell in 3 weeks at $3.30?
Everyone says we have 22 mil in the bank- enough until mid-2015. If Pascoe wants to pay off some debt with stock sales, he must have a good reason- as it hurts his option position. In a way, I'd say this makes him look like he's looking out for the company more than he's watching his piggybank.
Also, since he's one of the very few people who knows what's really happening at any moment, I have to conclude that they believe stock price appreciation will more than make up for any dilutive effect.
Might just be day traders taking profits from yesterday's run-up. Those 8K blocks being sold today match up with many of the 8K blocks bought yesterday- and a quick $600+ profit (for a trader)is hard to resist.
As for OTC Cialis, can you imagine how it will be abused? I don't think it will happen for a long time.
Nice to see some big trades going across. Over thirteen 3,000 share trades plus a 14,000 share trade at 12:56 and a 10,000 share trade at 1:03, and some 8,000 share blocks spread around.
Earlier in her career, she had been a product manager at Forest Labs (with all that entails), an analyst at UBS, and a graduate of the Stern School of Business. I don't believe she changes her opinion lightly and without information we probably don't have available to us.
In this case, it may be 'under promise (the new target) and over deliver (where it ends up in 30 days).'
Maybe we just hit the tipping point.
The day when simple external application of a cream really does the job, that company will have a billion dollars in sales within a year. Let's hope that target is what our scientists are aiming for and that APRI will be that company.
If our permeation enhancer really is that good, maybe we will be that company. Maybe Abbott is working on that very aspect of the product. They certainly have a deep enough R&D bench to do it.
Got to remember that the effect of this little cream lasts for up to 2 hours. Two hours. I don't know about any of you folks, but it's been decades since we needed more than half an hour to do our dancing.
What's this mean? Well, it means the dosing will need some tempering by trial and error until users get comfortable. Do you really want to take the big dose and then be told, "Ok honey, the Smiths are coming over for dinner in 45 minutes!" I guess your shirt won't be tucked in when you invite them in!
"Hi Bill, Hi Andrea."
"Loose shirt syndrome, eh? You just happy to see my wife?"
"Er, no Bill. It's the Vitaros effect. Won't go down until 7:30. I hope I didn't offend Andrea."
"Of course not. By the look in her eyes, I think I'd better give it a try myself!"
No matter what the first comments are, it will take some weeks before we really know how it has been received. Will that burning sensation crop up? Will a smaller dose fix it? Will a smaller dose make you 'good' for a 45 minutes and then dissipate? Is it uncomfortable for your partner?
Hey, I can take some heat down there (ever have a double Hunan Chicken? Goes down burning, comes out burning!) If it's uncomfortable for my wife I'd use a condom. She'd prefer it anyway- less mess to clean up!
For many men, this will be nothing less than a manhood saver, and nothing will prevent them from using it. There's a very large population of PDE5i users that are begging for something else, for many different reasons. Vitaros is the new kid on the block and it will take some time and effort to rattle the PDE5i pill pushers, but it will happen. If Takeda and the others in Europe have great ad campaigns and the physicians prescribe it because their patients ask for it, we'll have a remarkable summer and fall.
Have to agree with you, Zman. But they could use the opportunities to talk up the 'pipeline' and certainly other bigger companies would be present to consider a Femprox partnership. I guess it all comes down to seeing the first sales and waiting for the early reports from the users.
I see they have a 15 minute slot where Pascoe or Martin will probably read off the latest PowerPoint. Would it have been too much to have a booth in the exhibition hall?
For what it's worth, I think a presence at the GS Global Healthcare Conference, June 10-12, would have a bigger impact. The darn thing is only a 2 hour drive from the APRI office.
I sent an email to Angeli asking if someone would be there- got my 'read-receipt' back, but alas, no actual response. Has anyone gotten a response back from our new IR company? Do they actually DO anything??
6,490 shares traded so far- and took the price from 2.10 to 2.20. Just think what's going to happen when 300,000 or (dare I say it?) 3 million shares change hands in the coming month when multiple funds want in?
Most of those shares were traded in 1K and 2K blocks.
I am so ready for this.
Here's a link to an IR firm that has its act together.
http://sternir.com/industry-calendars/?ai1ec_cat_ids=7#action=ai1ec_month&ai1ec_month_offset=1
You'll notice that bioscience investor conferences happen all the time. We really should have some sort of presence at more of them.
Anyone know if APRI is presenting/attending/daydreaming of the Goldman Sachs 35th Annual Global Healthcare Conference 2014 in Rancho Palos Verdes, California?
This would be the place to present, wouldn't it? The opportune moment, as Captain Jack would say.
Just remember that all those many hundreds of thousands of stock options the execs gave themselves over the last few years are worthless right now. Worthless.
If you had a chance for a payday that could approach $75,000 for every point the stock moved (or in Pascoe's case, over $900,000/point), wouldn't you do everything under heaven to make it so? You bet your bottom dollar you would! If this goes under $2, I'm picking up more. The execs aren't the only ones who are going to pick up some spare change on this.
Anyone getting out now just doesn't get the story (or they're just day-trading it.)
7,833 by 10:51 on TradeStation. Whew! Any time it's below 2.14, smart buyers magically appear!
That's right. Wouldn't be the first time somebody downgraded a stock, quietly picked up a nice position, and then, on the slightest good news, 'reassessed' their rating to entice retail buyers.
The start of retail sales next month will be that reassessment. Doesn't it seem strange, with all these good-news announcements, that Zack's downgrades now, a month before the long-awaited rollout? I doubt anyone is listening to them.
Really, you think the guys that inject their peckers with the current stuff won't be lining up in droves to try V? I think every patient on that regimen will be an immediate candidate for a V prescription.
The anemic volume is interesting- nobody bailing out wholesale, yet very few big buyers either. (Of course, big buyers will force a price move, exactly what they don't want to happen.) Everybody seems to be happy right where they are.
I think we're in the 'calm before the storm' of the release. When the good reviews hit the wire services and the stock does start to move, we'll already be in our seats; everyone else will have to buy their tickets at the last moment- and those are always the most expensive.
The next question becomes: do I take out my original investment and have a free ride or stay all-in and see what this company can really do?
SB,
Sorry I missed you earlier messages. We're on the exact same wavelength. Dave
From the 2013 annual report:
On January 3, 2011, the Company entered into a license agreement with Elis Pharmaceuticals Ltd. (“Elis”), granting Elis the exclusive rights to commercialize Vitaros® for ED in the United Arab Emirates, Oman, Bahrain, Qatar, Saudi Arabia, Kuwait, Lebanon, Syria, Jordan, Iraq and Yemen (the “Elis Territory”). Under the license agreement, the Company is entitled to receive upfront license fees and milestone payments of up to $2.1 million over the term of the license agreement. The future milestones are tied to regulatory approval and the achievement of certain levels of aggregate net sales of Vitaros®. Additionally, the Company is entitled to receive escalating tiered double-digit royalties on Elis’ sales of Vitaros® in the Elis Territory.
On February, 14, 2011, the Company entered into a license agreement with the Neopharm Scientific Limited (“Neopharm”), granting Neopharm the exclusive rights to commercialize Vitaros® in Israel and the Palestinian territories (the “Neopharm Territory”) for ED. Under the license agreement, the Company is entitled to receive upfront license fees and milestone payments of up to $4.35 million over the term of the Neopharm Agreement. The future milestones are tied to regulatory approval and the achievement of certain levels of aggregate net sales of Vitaros®. Additionally, the Company is entitled to receive escalating tiered double-digit royalties on Neopharm’s sales of Vitaros® in the Neopharm Territory.
The only deliverable was the license element and given no additional obligation was associated with the license element, the aggregate of $0.2 million in up-front payments pursuant to the Elis and Neopharm licensing agreements was earned upon the delivery of the license and related know-how, which occurred by March 31, 2011, and therefore recognized in 2011 revenue.
_________________________
It would be nice if the company included them in the presentation. It would also be nice if they gave the current status of these agreements. My emails about this to the company and Angeli haven't been answered.
One would think Angeli (or Steve) would jump at the chance to talk to a shareholder, but I guess we're just not that important.
In takeovers, there's a way by which the buyer can get the names and addresses of every shareholder. I wonder if we can organize shareholder group to do that? It would be great to get those 13 million 'street shares' to actively participate in the running of this company.
Anyone up for coming up with shareholder proposals for the next annual meeting?
Anyone else notice that there was no reference to the Neopharm (Israel) licensing agreement in today's slide presentation? Is that still operational? Any movement on it?
Nice find, Akame! thanks
I'm not sure, but I'd guess that's all the stock held in 'street-name' at brokerages that didn't get voting instructions from the shareholders. That's a lot of stock that nobody seems to care about...
Link to latest company presentation:
http://irdirect.net/filings/viewer/index/1017491/000101749114000072/1
Annual meeting results link:
http://irdirect.net/filings/viewer/index/1017491/000101749114000072/
Results of annual meeting.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 15, 2014
Apricus Biosciences, Inc.
(Exact name of registrant as specified in its charter)
Nevada
0-22245
87-0449967
(State or other jurisdiction of
incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
11975 El Camino Real, Suite 300, San Diego, CA
92130
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code (858) 222-8041
(Former name or former address, if changed, since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13a-4(c))
1
Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
At the Annual Meeting of Stockholders of Apricus Biosciences, Inc. (the “Company”) held on May 15, 2014 (the “Annual Meeting”), Leonard Oppenheim’s term as a member of the Company’s Board of Directors (the “Board”) expired. Mr. Oppenheim elected not to stand for re-election at the Annual Meeting for personal reasons and his retirement from the Board was not related to a disagreement with the Company.
Item 5.07. Submission of Matters to a Vote of Security Holders.
The following is a brief description of each matter submitted to a vote at the Annual Meeting, as well as the number of votes cast for, withheld or against, the number of abstentions and the number of broker non-votes with respect to each matter, as applicable. For more information about these proposals, please refer to the Company’s proxy statement filed with the Securities and Exchange Commission (“SEC”) on April 7, 2014.
The number of shares of common stock entitled to vote at the Annual Meeting was 37,872,682. The number of shares of common stock present or represented by valid proxy at the annual meeting was 29,735,682. Certain matters submitted to a binding vote of stockholders at the Annual Meeting were approved as described below.
Proposal No. 1: Election of Class III Directors
Rusty Ray and Wendell Wierenga, Ph.D. were elected to serve as Class III directors. Mr. Ray received 12,792,515 votes for and 3,148,665 votes withheld, and Dr. Wierenga received 14,783,172 votes for and 1,158,008 votes withheld. There were 13,794,502 broker non-votes regarding the election of directors.
Proposal No. 2: Ratify Selection of Auditors
Stockholders ratified the appointment of PricewaterhouseCoopers LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2014. The results of the voting included 26,420,737 votes for, 2,973,660 votes against and 341,285 votes abstained. There were no broker non-votes regarding this proposal.
Proposal No. 3: Conduct an Advisory (Non-Binding) Vote on Executive Compensation
Stockholders approved, on an advisory basis, the executive compensation paid to the Company’s named executive officers. The results of the voting included 11,504,469 votes for, 3,564,902 votes against and 871,809 votes abstained. There were 13,794,502 broker non-votes regarding this proposal.
Proposal No. 4: Change of the Company’s Corporate Domicile from Nevada to Delaware
Stockholders did not approve the Company’s proposal to change the Company’s corporate domicile from Nevada to Delaware, which required a majority of the total outstanding shares of common stock in order to pass. The results of the voting included 13,758,029 votes for, 909,394 votes against and 1,273,757 votes abstained. There were 13,794,502 broker non-votes regarding this proposal.
Item 7.01. Regulation FD Disclosure.
On May 15, 2014, the Company provided an update to its corporate presentation. The presentation is currently available on the Company’s website and filed herewith as Exhibit 99.1.
The information set forth in this Item 7.01, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.
2
By filing this Current Report on Form 8-K and furnishing the information in this Item 7.01, the Company makes no admission as to the materiality of Item 7.01 in this report or the presentation attached hereto as Exhibit 99.1. The information contained in the presentation is summary information that is intended to be considered in the context of the Company’s filings with the SEC and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Item, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The Company cautions you that the presentation attached hereto as Exhibit 99.1 contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in the presentation that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the timing of planned launches and initial shipments of Vitaros® in various countries by the Company’s commercial partners, particularly the United Kingdom, the planned commencement of a Phase 2a clinical trial and approved pathway for RayVa™ and the planned out-license of Femprox® in Europe; the potential for Vitaros to achieve commercial success generally or in any specific territory; and the Company’s 2014 financial outlook, including cash projections. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of the Company, including, but not limited to: its ability to further develop its product Vitaros for the treatment of Erectile Dysfunction (“ED”), such as the room temperature version of Vitaros, and its product candidate RayVa for the treatment of Raynaud’s phenomenon, as well as the timing of such events; the Company’s ability to carry out clinical studies for RayVa, as well as the timing and success of the results of such studies; the Company’s dependence on its commercial partners to carry out the commercial launch of Vitaros in various territories, and the potential for delays in the timing of commercial launch; competition in the ED market and other markets in which the Company and its partners operate; the Company’s ability to obtain and maintain intellectual property protection for Vitaros; the Company’s ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; the Company’s ability to obtain the requisite governmental approval for Femprox and RayVa; and market conditions. These forward-looking statements are made as of the date of this report, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in the Company’s most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC’s website at www.sec.gov or without charge from the Company.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
Description
99.1
Corporate Presentation, dated May 15, 2014
Viagra worldwide sales of 1.88 billion in 2013 and slowing.
Cialis worldwide sales of 2.16 billion in 2013 and growing.
Pfizer has patent issues looming ahead for Viagra. Even if they can reformulate to get a patent extension, having a backup product is never a bad idea. Vitaros and APRI's pipeline seems like a no-brainer fit.
Can you imagine all those print and TV ads that now mention Viagra being altered to show both products? "Pick the one that's right for you!"
As much as I would love to see APRI at $25 or higher when full blown sales are rolling in, I think anyone who wants this company to bolster their existing products isn't going to wait too long before making a play for it.
Hopefully, some of the physicians that are in the product 'sample' group will personally test drive the product before prescribing it to their patients. If they have a strong positive response to it, then the fuse will have been lit and we just need to sit back while the June ETA rolls towards us. The rest, as they say, will be history. (Hey, it could happen!)
Can you imagine if it really takes 10-15% of the worldwide PDE5i market? Pfizer might make an offer just get this product in-house so as to give Viagra-prescribing physicians a 'one-stop' shopping opportunity.
Depending on market acceptance, if there is lots of positive talk from users, I think one of the PDE5i pill makers would quickly have to make an offer to bolster their product line. There's only one Vitaros and multiple PDE5i makers. Only one of them will be able to brag that have all the bases covered when it comes to men's health. And let's face it, for any of those companies, buying Apricus for $8 would be pocket change. I bet all of them already have their financial folks running the scenarios. They wouldn't be protecting their brands if they didn't.
Just a bit more info on the British Vitaros rollout. In a response from the 'Boots' pharmacy chain (2,500 stores):
Thank you for contacting us further.
Unfortunately as 'Vitaros' is not available until June here at Customer Care we do not have information as to whether we will stock this or not. Please accept our apologies for this.
Please speak to the pharmacist at your local store who may be able to help you further.
Just last week they weren't even familiar with the name, so things are ramping up nicely.
Let's face it, the company is going to have to put up some real earnings numbers before big buyers step in (or maybe some glowing customer reviews). You know, "fooled once, shame on you, fooled twice shame on me."
One month to lift off, in more ways than one for some Englishmen.
The new PR firm is obviously a mistake. They should have ensured representation from at least the website-listed analysts. The tiny fact that only one of them cared to dial in shows how the rest of them consider our company- a waste of their time. Irina couldn't even get a coworker to sit in for her!
I would recommend that APRI release the new company and hire someone (yes, a company employee) who will actually work promoting the company. That means contacting the research depts. of all the major brokerage houses, contacting all the mutual fund managers and biotech research analysts, reserving space at every biotech convention/meeting held in the USA and Europe, sending mailings to every urologist and family practice physician in the EU and Canada and every other country where Vitaros is about to be available. And even where it's not- so as to create some interest/demand for it. If they drop ship all the materials, I'll do it myself!
I swear these PR companies must all think they're doing their jobs by just holding the damn quarterly announcement! Hell, I could monitor the phone calls and announce Rich and Steve! If Angeli (SVP, no less!) thinks she's fully performed her duties, she's terribly mistaken.
Yesterday's meeting should have been a blowout celebration- that finally, after years and years of delays, product has finally made it into the hands of some physicians. But it was announced with a whimper- and nobody even came to the party.
If we don't see immediate, real, and measurable improvement in Angeli's performance, she and her company need to be fired. The company is in the 'Blastoff' stage but our PR company, of all people, doesn't seem to get. I can only imagine how the annual meeting will go...
Who knows? Maybe $2.56 will look very cheap tomorrow.
Guys, before you go emailing anyone in Lebanon for any information, remember that the country is run by Hezbollah, an organization on the USA's bad-guy list. I would presume that any and all emails from the USA to anyone in Lebanon are seen by the CIA/NSA etc. I want to know as much about the progress of Vitaros as anyone, but I don't think I want the Feds watching everything I do for the rest of my life, as boring as it might be. Just a thought. If someone from Europe or the Mideast can provide any new info, many thanks.
I suppose a shareholder could propose a 'no confidence' resolution for next year's annual meeting, but for now, I believe we need to sit tight and see what the rest of the year brings. The board already knows how we feel from the votes received. They know we've been patient. They know they've under-achieved in the past. They know they've been very well compensated over the past few years for what they have accomplished. (It's like Obama getting the Nobel Prize for what he SAID he wanted to do!)
They know that they are sitting on a shareholder revolt which can only be calmed down by timely real accomplishments.
The fact that Recordati has actually mentioned Vitaros and has it on their website is a great step forward. We have to give Pascoe and his team a little more breathing room. I think we all agree that if sales really begin this year in multiple countries, nobody will begrudge the execs their salaries.
Many of us have waited for years- years of 'round trips' from yearly highs to less than our purchase prices. (And we all know what a crappy feeling that is!)
Even Apple fell on its face for several years- so we need to let Pascoe execute his plan since it appears to have traction.
In any case, I'm staying put and will pick up more when the right price presents itself.